BELLEVILLE, ON, Feb. 13 /PRNewswire-FirstCall/ - Bioniche Life Sciences Inc. , a research-based, technology-driven Canadian biopharmaceutical company, is pleased to provide an update on the progress of its North American clinical trial with Mycobacterial Cell Wall-DNA Complex (MCC) - trademarked Urocidin - in patients with non muscle-invasive bladder cancer that is refractory to the current standard therapy. This indication was given Fast Track designation by the U.S. Food and Drug Administration (FDA) in April of 2006.
The Company commenced this trial in November, 2006. An investigators’ meeting was held in April, 2007, and the trial has been progressing steadily since that time.
On February 7, 2008, the Data Safety Monitoring Committee held its third meeting regarding this clinical trial. The role of this independent body is to confirm that the safety of enrolled patients is being appropriately addressed and that, from an efficacy point of view, there is an appropriate basis for continuing the trial. After its meeting, the Committee has recommended that Bioniche “continue the trial unmodified until the next scheduled or triggered meeting.” The next meeting of the Committee will be held in three months.
Patients are being enrolled in the trial’s 25 sites on a regular basis. The targeted enrollment of this study is 105 patients which, coupled with additional safety information collected from a comparative trial, will allow full results to be reported one year after recruitment is completed for the efficacy and safety datasets. These results may also support regulatory submissions under FDA’s Accelerated Approval program.
Bioniche is planning to conduct a second registration study in bladder cancer; a trial which will directly compare the efficacy of Urocidin with the incumbent therapy for non muscle-invasive bladder cancer. In September, 2007, the Company announced that an agreement has been reached with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure. This indicates agreement by the FDA on the design of the study, including its endpoints, data analysis and conduct. It provides assurance that, if the trial endpoints are met, they will serve as the basis for product approval under a Biologics Licensing Application (BLA). A SPA gives a clear pathway to registration of Urocidin when the study endpoints are achieved.
Bioniche plans to begin recruitment of patients for the second pivotal study later this year. The study will enrol approximately 800 patients in North America, Australia and Europe and is a double-blind, randomized study. It will compare MCC to the standard treatment for non muscle-invasive bladder cancer at high risk of recurrence or progression - Bacillus Calmette-Guerin (BCG). BCG is a live, attenuated strain of Mycobacterium bovis and is often associated with treatment-limiting side effects including active bacterial infections.
Bioniche also continues to have discussions with potential development and marketing partners, and the Company is well positioned and committed to execute a strategic partnership transaction related to the financing of Urocidin at the earliest opportunity.
About MCC
MCC is a sterile mycobacterial cell wall composition that has a dual mode of action: immune stimulation and direct anticancer activity. It is formulated as Urocidin(TM) for the treatment of bladder cancer, where it is administered by the intravesical route directly into the bladder, coming into contact with immune system cells and bladder cancer cells. MCC is also undergoing preclinical evaluation as a treatment for peritoneal carcinomatosis associated with colon and ovarian cancer.
About Bioniche Life Sciences Inc.
Bioniche Life Sciences Inc. is a research-based, technology-driven Canadian biopharmaceutical company focused on the discovery, development, manufacturing, and marketing of proprietary products for human and animal health markets worldwide. The fully-integrated company employs approximately 200 skilled personnel and has three operating divisions: Human Health, Animal Health, and Food Safety. The Company’s primary goal is to develop proprietary cancer therapies supported by revenues from marketed products in human and animal health. Bioniche has been named one of Canada’s Top Ten Life Sciences Companies for 2008. For more information, please visit www.Bioniche.com.
Except for historical information, this news release may contain forward-looking statements that reflect the Company’s current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process, and other risks detailed from time to time in the Company’s ongoing quarterly and annual reporting.
CONTACT: Jennifer Shea, Corporate Communications, Investor & Government
Relations Director, Bioniche Life Sciences Inc., Telephone: (613) 966-8058,
Cell: (613) 391-2097, Jennifer.Shea@Bioniche.com
